Overview

This trial is active, not recruiting.

Conditions occupational health, hazardous material handling
Treatment hazardous materials online education and study feedback
Sponsor University of Michigan
Start date March 2015
End date April 2017
Trial size 380 participants
Trial identifier NCT02283164, 1R01OH010582-01

Summary

The goal of this research is to evaluate the efficacy of an audit and feedback intervention to improve personal protective equipment (PPE) use by nurses who handle hazardous drugs in the ambulatory oncology setting.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
Hazardous materials online education and study feedback
hazardous materials online education and study feedback
Participants will receive a 45-minute educational webinar on hazardous materials handing best practices at the beginning of the intervention period. Subsequently they will receive quarterly feedback of interim study results.
(Active Comparator)
Hazardous materials online education and study feedback
hazardous materials online education and study feedback
Participants will receive a 45-minute educational webinar on hazardous materials handing best practices at the beginning of the intervention period. Subsequently they will receive quarterly feedback of interim study results.

Primary Outcomes

Measure
Usage of PPE
time frame: Baseline (Year 1) and follow-up (Year 3)

Secondary Outcomes

Measure
Potential Mediators
time frame: Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Organization
time frame: Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Personal
time frame: Baseline (Year 1) and follow-up (Year 3)

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - registered nurses - employed 16 hours or more per week in the ambulatory chemotherapy infusion area Exclusion Criteria: - Treatment with an antineoplastic agent in the past year.

Additional Information

Official title Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use
Principal investigator Christopher R Friese, PhD
Description The overall objective of the proposed study is to investigate exposures to hazardous antineoplastic drugs among oncology nurses who handle them. The specific project objective is to evaluate the efficacy of an audit and feedback intervention to improve PPE use by nurses who handle hazardous drugs in the ambulatory oncology setting. This project will pursue three specific aims: 1. Evaluate the efficacy of an audit and feedback intervention to improve recommended use of PPE; 2. Determine whether the intervention effects on PPE use are mediated by knowledge about PPE use and perceived risk of hazardous drug exposure, and; 3. Determine whether the intervention effects on PPE use are moderated by personal (experience, education, certification) and organizational factors (workloads, practice environments, safety organizing). To achieve these aims, 382 nurses employed in 11 oncology centers will participate in a cluster randomized controlled trial. Sites will be randomized so participants will receive a one-hour web-based educational module on hazardous drug safe handling with quarterly email reminders about the educational content (control) or the web-based educational module plus quarterly feedback on hazardous drug spills and drug levels measured in the study population (treatment). The hypothesis is that nurses in sites who receive the treatment will report significantly higher PPE use compared to nurses in sites assigned to receive the control. Data will also identify organizational factors that can be targeted for future interventions.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Michigan.